RecruitingRecruiting
Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research
NCT07623668 · Oculis
In plain English
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Official title
A Randomized, Double-masked, Placebo-controlled Study Assessing the Efficacy and Safety of Privosegtor (OCS-05) in Patients With Optic Neuritis (ON)
About this study
The goal of this clinical trial is to evaluate the safety and efficacy of privosegtor, a neuroprotective candidate, in patients diagnosed with optic neuritis (ON).
Researchers will compare privosegtor and the standard of care (methylprednisolone) to a placebo and standard of care (methylprednisolone).
Eligibility criteria
Key Inclusion Criteria:
* Adult men and women (aged 18 to 50 years) with the first episode of ON in the study eye, associated with unilateral visual loss.
* Onset of visual loss symptoms in the previous 12 days before first administration of study treatment.
Key Exclusion Criteria:
\- Have a history or presence of any disorder or condition that may, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety
Study design
Enrollment target: 210 participants
Allocation: randomized
Masking: quadruple
Age groups: adult
Timeline
Starts: 2026-05-28
Estimated completion: 2028-12
Last updated: 2026-06-03
Interventions
Drug: PrivosegtorDrug: MethylprednisoloneOther: Placebo
Primary outcomes
- • Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA). (3 months)
Sponsor
Oculis · industry
Contacts & investigators
ContactChief Development Officer · contact · info@oculis.com · 617-928-5886
All locations (1)
Neuro-Eye Clinical TrialsRecruiting
Houston, Texas, United States